Health Care Quarterly:

Clinical trials are a vital step in improving health care in Southern Nevada and beyond

The joke is old and tired by now, and as time goes on it becomes more nonsensical: “If you want quality medical care in Las Vegas, the best place to go is McCarran International Airport.”

The common perception was that major medical centers elsewhere were the place to go for trend-setting treatment and medical advances.

While there is much room to grow and advance, with the establishment of the UNLV School of Medicine and the expansion of other medical schools such as Touro University Nevada, Roseman University of Health Sciences College of Medicine and the Nevada State College School of Nursing, significant advances are being made to ensure quality, ground-breaking care.

In fact, medical research is taking place here, in the form of clinical trials. Clinical trials, like many medical-related terms, are something many of us have heard but likely have only vague notions about what they really are.

What is a clinical trial?

Clinical trials are research studies performed on people with the goal of evaluating a medical treatment. It’s the primary way that researchers find out if a new treatment (e.g., a new drug, medical device or other proposed treatment) is safe and effective. Often, a clinical trial is used to learn if a new treatment is more effective or has fewer side effects than standard treatments.

Phases of clinical trials

Clinical trials advance through four phases to test a treatment, find an appropriate dosage and to look for side effects. If researchers find a drug or other treatment to be safe and effective after the first three phases, the U.S. Food and Drug Administration approves it for clinical use and continues to monitor its effects.

Phase I trials determine a safe dose of the treatment being studied and monitor how the treatment affects the human body.

Phase II trials determine if the new treatment is effective and monitor for possible side effects.

Phase III trials gather more information about safety and effectiveness, continue to monitor for side effects and compare the new treatment with the current standard treatment. If the FDA agrees that the trial results are positive, it will approve the experimental drug or device.

A Phase IV trial takes place after the FDA approves use and after the drug or treatment has been marketed. Sometimes, the side effects of a drug may not become clear until more people have taken it over a longer period of time.

Clinical trials in Southern Nevada

There are a substantial number of clinical trials taking place in Southern Nevada — more than 2,000 of them, according to ClinicalTrialsGPS.com.

Among the clinical trials now available is one that could help cancer patients all over the world. Dr. K. Saad Jahangir of OptumCare Cancer Center has launched a multinational Phase III clinical trial aimed at reducing the incidence of inflammation in patients receiving chemotherapy radiation for head and neck cancer. With head and neck cancer, oral inflammation will sometimes lead to trouble eating and even hospitalization.

“The goal is to make sure patients are comfortable and can withstand the sometimes-harsh chemotherapy treatments for cancer,” said Jahangir, principal investigator and lead physician for the Nevada division of the trial, a pharmaceutical trial opened in alliance with the Nevada Cancer Research Foundation.

“The medication in this trial is intended to reduce inflammation, so patients find it easier to eat,” he said. “Ultimately, our intent is to make chemo more tolerable and more effective for patients.”

The medicine being tested is an “immune modulator.” The human cellular immune system is made up of a whole array of different cells that work together to protect the body from disease. These various cells have to be present in the correct ratios to one another in order to function effectively together. Chemotherapy, while attacking cancer, can disturb this balance.

“The intent is to use this immune modulator medication to reduce the incidence of oral inflammation and ulcer formation caused by chemo-radiation therapy,” said Jahangir. The goal is to make chemotherapy and radiation therapy more tolerable for patients so that they can continue their therapies on schedule without delays and potential hospitalizations.

“We’re in the very early stages of developing our clinical trials program, and much more work is needed,” said Jahangir. “As we progress, we want our patients and the community to become part of this journey with us. Our philosophy is a holistic approach where mind, body and soul have to be in synergy to get the best therapeutic outcomes.”

Why do clinical trials matter?

Advances in medical research improve our future. Simply put, without patients’ willingness to participate, research for cures can’t move forward. Finding new, safer and more tolerable treatments is important to all of us.

“The ability to conduct clinical trials further shows our commitment to provide cutting edge molecular biology and technology-based treatment options for our patients,” said Jahangir.

Unfortunately, there are still many conditions without cures or treatments. Research studies offer hope to patients who may have exhausted all other treatment options.

Looking ahead

The FDA has been leading efforts to include older adults in trials since 1983, but they are often one of the least represented groups in clinical trials. The FDA finalized guidance in 1989 on including patients over the age of 65 in clinical trials, and, more recently, an amendment to the guidance encourages the inclusion of patients over 75.

“I believe it’s imperative that we focus on efforts to enroll more geriatric patients in clinical trials and find better solutions for them,” said Jahangir. “Age is just a number. What truly matters is how physically fit one is at that age, which ultimately drives therapeutic interventions.”

Jahangir believes this is an exciting time to practice oncology due to rapid advancements in science and technology. “We’re exploring treatments at molecular levels, targeting pathways with novel compounds that drive malignancies and harnessing our own immune system to fight cancer.”

Dr. Russell Gollard is medical director of OptumCare Cancer Care.

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